GROW (Glioma Specialists Reaching Out With Support) Support

• Sponsor: Dana-Farber Cancer Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05233215
• Collaborator: Levitan-Zabin Fund (Other)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 23.5
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

This research study is being done to test a participant and caregiver-driven model of follow-up survivorship care,GROW Support (Glioma Specialists Reaching Out With Support), for post-treatment, low grade glioma patients.

Condition or Disease	Intervention/Treatment	Phase
Low-grade Glioma; Survivorship; Care Giving Burden	Behavioral: GROW (Glioma Specialists Reaching Out With Support) Support Program	N/A

Detailed Description

This research study is a Feasibility Study, which examines if a supportive intervention for people with low grade gliomas (LGGs) and their caregivers is acceptable and feasible to patients and their caregivers.

The research study procedures include: screening for eligibility and study interventions including filling out questionnaires and virtual or in-clinic supportive follow up visits to identify additional supportive needs that may arise.

Participants will be in this research study for up to 6 months.

It is expected that about 40 people will take part in this research study.

The Levitan-Zabin Fund for GROW Support is supporting this research study by providing funds for research team members to do this study.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: GROW Support (Glioma Specialists Reaching Out With Support): Assessment of a Comprehensive Support Program for Low Grade Glioma Patients Post-treatment
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Dec 15, 2023
• Anticipated Study Completion Date: Jun 15, 2024

Arms and Interventions

Arm

Intervention/Treatment

Experimental: GROW Support Program Patient participants will fill out questionnaires about emotional and physical health with responses used to develop an individualized survivorship plan conducted through 1x monthly virtual or in-clinic check-ins as well as GROW support meetings as needed for 6 months. Caregiver participants will fill out questionnaires used to develop patient individualized survivorship plan and participate in 1x monthly check-in meetings with patients or separately for 6 months.

Behavioral: GROW (Glioma Specialists Reaching Out With Support) Support Program; Follow-up survivorship care plan for patients and caregivers; Other Names: Support Program

Outcome Measures

Primary Outcome Measures

1. Retention Rate [6 months]

   Primary outcome is feasibility as defined by 60% of the eligible participants and their caregivers being recruited into the study and completing the initial assessment and associated survivorship plan

Secondary Outcome Measures

1. Abbreviated Acceptability Rating Profile [6 months]

   Acceptability of this supportive program ("GROW Support") for patients and their caregivers will be assessed by the Abbreviated Acceptability Rating Profile and based on in-depth semi-structured interview with one of the study investigators.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient inclusion criteria include:

• Must be at least 18 years of age;

• Diagnosed with low grade glioma (WHO grade 1 or 2)

• Completed active treatment within the last 2 years and are undergoing surveillance follow-up

• Must have at least one caregiver willing to participate as indicated below

• Read and comprehend English such that they are able to complete required intervention sessions and psychosocial battery in English and are able to understand and willing to sign an electronic informed consent document.

• Confirms willingness to undergo initial and follow-up questionnaire battery.

• Caregiver inclusion criteria include:

• Must be at least 18 years of age

• Read and comprehend English such that they are able to complete required intervention sessions and psychosocial battery in English and able to understand and willing to sign an electronic informed consent document

• Consider themselves personally involved in the patient's care and decisions about the care they receive.

Exclusion Criteria:

• Bipolar disorder,

• Psychotic disorders and

• Confusion or altered mental state that would prohibit understanding and giving of informed consent. However, if the patient's bipolar disorder or psychotic disorder is currently treated/managed, the patient will be eligible for the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Dana-Farber Cancer Institute
• Levitan-Zabin Fund

Investigators

• Principal Investigator: Timothy S Sannes, PhD, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Timothy S. Sannes, Principal Investigator, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT05233215
• Other Study ID Numbers: 21-650
• First Posted: Feb 10, 2022
• Last Update Posted: Feb 10, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Timothy S. Sannes, Principal Investigator, Dana-Farber Cancer Institute: Low-grade Glioma; Survivorship; Care Giving Burden
• Additional relevant MeSH terms: Glioma; Caregiver Burden

Study Results

No Results Posted as of Feb 10, 2022